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									Appendix 6

Consultation Document concerning Registration, Evaluation, Authorisation and Restrictions of Chemicals (REACH) OCCUPATIONAL DISEASES IN THE EUROPEAN CHEMICAL INDUSTRY – IMPACT OF REACH
Cefic Comments – 8 July 2003

Occupational Diseases in the European Chemical Industry – Impact of REACH
Table of Contents
1. 2. 3. 4. 5. 6. 7. Executive Summary Occupational diseases in Industry Exposure situation in chemical industry Prevention of occupational diseases The European Commission (RPA) Final Report – Assessment of the Impact of the New Chemicals Policy on Occupational Health (March 2003) Conclusions References

1.

Executive Summary

The Key points of the Cefic response on this issue are as follows:      Occupational exposures to known chemical carcinogens are decreasing (measured data) – this should lead to visible reductions in occupational cancer cases in future years (latent period, burden of the past) The majority of current occupational cancers (67-85%) are due to asbestos, which is regulated separately from substances normally falling under chemical control regulations. Observed mortality/cancer morbidity in the chemical industry is similar to or better than the general population Levels of occupational disease are lower in the chemical industry than in other major industries (Building, Metals) EC estimations of the occupational health benefits of REACH are based upon assumptions, especially the presumed reduction of occupational cancer cases due to unknown chemicals. No account is taken of similar reductions resulting from improved workplace management, health monitoring and chemical risk assessment activities already in place.

2.

Occupational diseases in Industry

A study has been conducted to compare the incidence of occupational diseases in the chemical industry with that in other sectors. The findings indicate that the chemical industry is not particularly affected by occupational diseases. The relevant data are available from national statistics. The study used the numbers of acknowledged occupational diseases reported by the German Statutory Accident Insurance Fund as an example which can probably be seen as representative for the highly industrialised countries within the European Community (Figure 1). For the interpretation of the time trend two important facts have to be considered. Firstly, since 1991 cases originating in the former German Democratic Republic have been included in the statistical data. Secondly, in 1992 the list of compensatable occupational diseases had been enhanced accordingly. These two factors account for the substantial increases in occurrence across all sectors from 1992 onwards.

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Figure 1: Number of acknowledged occupational disease cases in different industries in Germany

6000 5000 4000 3000 2000 1000 0 Chemical Industry Building Metall industry Stone and Earth 1980 1982 1984 1986 1988 1990 1992 1994 1996 1998

Is there any predominant cause for occupational disease? According to the German Statutory Accident Insurance Fund, the most important causes is noise (37%), closely followed by inorganic dusts (32%) [HVBG 2001]. Both of these are already subjected to specific and separate legislation. By comparison, other causes of disease lead to much fewer cases of illness. The data in Figure 2, where major causes of occupational diseases are displayed, illustrates this statement. Thus, even if occupational diseases due to noise are excluded, typical industrial chemicals do not play a major role in the causation of the remaining fraction.

Figure 2: Some causes for occupational diseases in the German industry [HVBG]

2000 1800 1600 1400 1200 1000 800 600 400 200 0 chemicals inorganic dust 1980 1982 1984 1986 1988 1990 1992 1994 1996 1998

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This is obviously also true if it comes to cancers. Data from EUROGIP (2002 – see references) indicate that the majority of occupational cancer cases in EU countries are due to asbestos exposure (67 – 85%). This is in accordance with German data, where from the total of occupational cancer cases recorded between 1978 and 2000, asbestos accounted for 69.8%, ionising radiation for 14.8%, PAHs for 2.2%, wood dust for 2.2%, and crystalline silica for another 1.5% [Butz 2002]. Thus, less than 10% of occupational cancers are attributable to synthetic substances normally falling under chemical control regulations, which include for instance aromatic amines (4.7%) and benzene (1.9%). It should also be understood that cancers occurring now are likely to be due to exposures which occurred 2-3 decades ago when less stringent workplace Health and Safety regimes were in place.

Figure 3: Causes for occupational cancer in Germany [Butz 2002]

Asbestos radiation PAH's silica aromatic amines benzene

3.

Exposure situation in chemical industry

The Chemical industry had started exposure reduction programs many years ago. These programs were initiated on one hand to improve the workplace situation and to reduce the risk of handling chemicals and on the other to reduce the emissions to the environment. Figure 4 a and b show for some important carcinogens the exposure situation in some of the big German chemical industries. A dramatic decrease of the measured exposure (mostly done by personal sampling) can be seen for this 23 year time period. Figure 4: Exposure situation for important carcinogens in German chemical companies. a) Bayer-AG, all values in [ppm]

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40 35 30 25 20 15 10 5 0 1980-84 1985-89 1990-94 1995-99 2000-03 Acrylonitrile Butadiene Benzene Chloroaniline Benzylchloride Diaminodiphenylmethan Dichlorethane Ethylenoxide Propylenoxide o-Toluidin

b) BASF-AG, all values in [mg/m3]

3 2.5 2 1.5 1 0.5 0 1980-84 1985-89 1990-94 1995-99 2000-2003 Acrylonitrile Vinylchloride Butadiene Chloroaniline Ethylenoxide Propylenoxide o-Toluidin

However it is not only for the known carcinogens that the improvement of the exposure situation has been realized. All other chemicals, handled in the same or similar plants, are likely to have had similar exposure reductions. In this twenty year time-period, exposure was decreased by more than a factor of ten. If now a new carcinogen would be recognized, the health risk would be substantially reduced due to better workplace management compared with that in place a decade before. Figure 5 shows the exposure for some selected chemicals of great industrial importance.

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Figure 5: Exposure situation for important non-carcinogenic chemicals in chemical companies.

4 3.5 3 2.5 2 1.5 1 0.5 0 1980-84 1985-89 1990-94 1995-99 2000-03 Ethylacrylate n-Hexane Cyclohexanon Aniline Phthalicanhydride

4.

Prevention of occupational diseases

Will occupational diseases be further reduced by REACH? This is unlikely in the chemical industry since our current practice is to protect health on the basis of worst case assumptions. More information properly presented may improve occupational health in industries which use chemicals, but only if effective enforcement measures are put in place. Rigorous exposure management is the key to improved health protection.

5.

The European Commission (RPA) Final Report – Assessment of the Impact of the New Chemicals Policy on Occupational Health (March 2003)

This report purports to document the proposed benefits in terms of improved occupational health resulting from the EU Chemical Policy Review REACH provisions. It specifically proposes that there will be a substantial reduction of between 2167 and 4333 occupational cancer cases caused by unknown chemical carcinogens per year. The methods on which these estimates are based do warrant a second look. The RPA study uses the total number of cancer cases occurring in Europe, on which they apply estimated occupationally attributable proportions published elsewhere [Doll and Peto 1981, Morrell et al. 1998, ILO 2000]. The main flaws in their approach are: 1) the simplistic assumption of occupational exposures being equal to hazardous substances being equal to "chemicals". They disregard the fact that most of the cancers included in these proportions are not related to industrial chemicals and thus to substances which would fall under the regulation of REACH. This apparently led the authors to erroneously interpret some of their sources. The 6

following quotation makes this obvious: "The Australian study [Morell et al. 1998] utilises the Doll and Peto percentages of cancer deaths that can be attributed to occupational exposures and then makes assumptions on the number of cancer deaths due to occupational exposure to chemicals" [RPA 2003]. As a matter of fact, Morrell and co-workers never made this mistake but constantly referred to cancers caused by "hazardous substances". This is in line with Doll's and Peto's approach which explicitly includes cancers resulting from exposure to asbestos, combustion products, and other "non-chemicals" [Doll and Peto 1981]. Thus, the assumed number of 32,500 cancer cases attributed by RPA to "chemicals" is ill-founded, and so is the arbitrarily derived number of 6,500 cancer cases (assumed to be 20% of 32,500) which are attributed to "unknown chemical carcinogens". From these, one third (2,167) and two thirds (4,333) are then proposed as lower and upper bound estimates respectively of the number of cases assumed to be prevented in the future through REACH, without any contribution from established activities such as worker health monitoring or chemical risk assessment activities. 2) the assumption that cause and effect are immediate, whereas they are not. Cancer from industrial exposure will be reduced irrespective of this proposed legislation ; this will occur because of much lower levels of exposure over the last 10-15 years. Thus, although the report purports to be based upon an impressive array of sources for much of its data, its final estimation of the numbers of occupational cancers arising from unknown chemicals is not derived from any recognised source or formal analysis, but from simple assumptions and erroneously interpreted sources.

6.

Conclusions

The performance of the chemical industry in improving workplace hygiene and reducing occupational exposure to chemicals and carcinogens has clearly advanced. This is expected to lead to reductions in chemical-related occupational diseases including cancer. Levels of occupational disease in the chemical industry compare favourably with other major industry sectors ; it is also well established that observed mortality and cancer morbidity in the chemical industry is similar to or better than that of the general population (Greenberg et al., 2001). We recognise that the high standards of occupational health which are common in our industry do not apply universally to all industries where chemicals are used. However, the REACH proposals do not address the problems of the existing regulations which are already in place: Safety Data Sheets are not read/acted upon so that it is likely that the more bureaucratic Chemical Safety Reports will make matters worse. Manufacturers of chemicals cannot be expected to enforce occupational health standards in customers – that is the role of the authorities. Cancer cases appearing today go back to exposures which occurred 10-40 years ago (the latency period). These well known exposures have already been dealt with via specific regulations. Under current EU Notification requirements, new substances undergo at least basic toxicity testing (including mutagenicity) prior to marketing. There are no indications from occupational epidemiology which point to risks at today’s workplaces, comparable with those due to asbestos, benzene, and certain aromatic amines at workplaces in the past (Peto 2001). Thus, extrapolating the number of possibly avoidable future cancer cases on the basis of today’s incidence rates must necessarily result in an overestimate. These considerations plus the weaknesses in the EC/RPA report itself, throw substantial doubt upon the fundamental basis of the the EC’s claimed occupational health benefits arising from the REACH provisions.

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7.

References

Berufsgensossenschaft der chemischen Industrie Butz M: Beruflich verursachte Krebserkrankungen. HVBG (Hrsg.), Sankt Augustin (2002) Doll R, Peto R: The causes of cancer. J. Natl. Cancer Inst. 66 (1981), 1191-1308 EUROGIP. Overview of Occupational Cancers in Europe, December 2002, Eurogip-02/E Greenberg R.S. et Al. (2001). A meta-analysis of Cohort Studies describing mortality and cancer incidence among chemical workers in the United-States and Western Europe. Epidemiology, 12 (n°6), 727-740. Hauptverband der gewerblichen Berufsgenossenschaften (HVBG) (Ed.): BK-DOK Dokumentation des Berufskrankheiten-Geschehens in Deutschland. Sankt Augustin (2001) '99.

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